Clinical trial

Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

Opening soon · Not applicable · 1 countries · Registry ID NCT07696403

Opening soonNot applicableInterventional

What this study is about

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. This study aims to examine the impact of a low dose of pecans on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk. The specific aims of this study are to: * Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on fasting and postprandial blood lipids. * Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on other markers of chronic disease risk. Participants will be asked to: * Consume pecans daily for 12 weeks or maintain their current habitual diet. * Attend two short visits at 4 and 8 weeks for fasting blood draws, body measurements, and to collect their next 4 weeks' supply of study materials. * Attend two longer (5 h) testing visits, which include eating a standard breakfast meal and having their blood drawn periodically before and after breakfast. Researchers will compare the Pecan and Control groups to examine the physiologic effects of incorporating a low dose of pecans into one's diet.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionNutrition, Healthy, Dyslipidemia, Overweight and Obesity

Full registry criteria

Inclusion Criteria: * 25-75 year-old men and women at increased risk for cardiovascular disease. Increased risk for cardiovascular disease will be defined by either elevated cholesterol profiles -or- overweight/obesity. * Elevated cholesterol profiles will be defined as: * "Borderline High" and/or "at risk" in two or more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) --or-- "High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL). * Overweight/obesity will be defined by body mass index (overweight \> 28 kg/m2 or obesity 30 kg/m2 or greater). Exclusion Criteria: * Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative. * Women on hormone replacement therapy less than 2 years. * Women who are pregnant or nursing * Individuals who regularly exercise more than 3h/w * Weight gain or loss of more than 5% body weight in the past 3 months * Plans to begin a weight loss/exercise regimen during the trial * History of medical or surgical events that could affect digestion or swallowing * Gastrointestinal surgeries, conditions, or disorders * Any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease) * Metabolic disease * Atherosclerosis * Previous MI or stroke * Cancer * Fasting blood glucose levels greater than 126 mg/dL * Blood pressure greater than 180/120 mmHg * Medication use affecting digestion, absorption, or metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles * Medically prescribed or special diets * Food allergies (specific to the foods in the study, including tree nuts, dairy, gluten, palm oil, and coconut oil) * Fish oil supplements * Individuals who regularly consume nuts and/or nut butter (defined as consumption of \>2 servings (\~56g) of tree nuts, nuts, or nut butter (e.g., peanut butter, almond butter) per week * Excessive alcohol use (greater than 3 drinks/day for men; greater than 2 drinks/day for women) * Tobacco or nicotine use * Underweight BMI (\<18.5 kg/m²) * Individuals who have donated blood or plasma in the past 2 weeks * Anemia or hemoglobin levels \<13.0 g/dL (men) or \<12.5 (women)

Treatments and study arms

Pecan

Other

Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.

Control

Other

Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption and limit nut butters to no more than twice per week for the entire 12-week intervention period.

Primary outcomes

Change in fasting serum lipoprotein and cholesterol concentrationsbaseline, 12 weeks

The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)

Change in fasting and postprandial plasma lipid concentrationsbaseline, 12 weeks

The concentration of plasma triglycerides and non-esterified fatty acids before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Georgia🇺🇸 Athens, Georgia, United States

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Jamie A Cooper, PhDContact

Email · Call 706-542-4378

Jamie A Cooper, PhDPrincipal Investigator